has established numerous guidelines that the pharmaceutical industry must follow to A) ensure the quality of the medicines it produces and B) make sure that the medicines arrive safely in the hands of the consumer. When you’re working in the pharmaceutical industry, these ‘Good Manufacturing Practice
’ (GMP) regulations can seem overwhelming at times. No worries, though! We compiled the WHO’s GMP regulations into a checklist you can easily use before an inspection – or whenever you need to refresh your knowledge.
1. Control the entire manufacturing process
Not only the final product, but also the raw materials
must be checked for quality. If rejected, the materials must be stored in a quarantine area. Additionally, each product must have a record
outlining its specifications, manufacturing procedures, compliance history, and the maintenance schedules and procedures for the equipment and areas it involves. Each product must also have a batch or lot number.
2. Test your processes and equipment regularly
To ensure safe and reliable production processes, the WHO requires pharmaceutical manufacturers to test both the quality of their equipment and production processes on a regular basis and record
the outcome of those tests.
3. Keep a logical facility lay-out
In order to avoid mix-ups, errors and cross contamination, it is crucial for manufacturers to have a linear manufacturing process
. That means a final product never has to pass through or be near areas where raw materials or intermediate products are located.
4. Record procedures
The manufacturer must put good procedures in place, which all employees must follow, and all these procedures must be recorded. All employees must have easy access to the recorded procedures. It is advised to perform usability tests
to ensure all employees are able to fully grasp all procedures.
5. Keep accurate records of all products
The manufacturer must keep accurate records of the entire history
of each batch, from raw materials to distribution.
6. Define tasks clearly
All employees must have a full understanding
of their daily tasks and responsibilities to avoid misunderstandings and safeguard product quality. Tasks and responsibilities should not overlap nor have gaps.
7. Train your employees
All employees who have to enter laboratories or production areas must have received appropriate training, both on the job and in GMP practices. New equipment
must always come with additional training.
8. Develop a sanitation program
Good hygiene is key to reduce the risk of contamination. Naturally, all employees must be made aware of good hygiene practices
. These practices must be recorded and the records must be accessible to all employees.
9. Written maintenance schedule
All facilities and equipment must be included in a written maintenance schedule, both for scheduled and emergency maintenance.